COHEN DISTRACTOR by HOWMEDICA LEIBINGER, INC.

This product is intended for use in the treatment of cranial, midface, or mandibular conditions for which reconstructive oscotomy and segment are indicated. This includes conditions such as, syndromic cramosynostosis, midfacial cetrusion, hemifacial microsomia, und mandibular micrognathia. The device is mended to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones

Device Description

This device is a distraction system consisting of the following major components; distractor frame, plates, machine screws, flexible shaft, and distraction key. The plates and frame initially stabilize and then gradually distract the osteotomy. The flexible shaft, covered with a protective sheath, is connected to the frame and provides the point of attachment for the key used to initiate the distraction of the osteotomy.

AI/ML Overview

The Cohen Distractor is a bone distraction system intended for use in the treatment of cranial, midfacial, or mandibular conditions requiring reconstructive osteotomy and segment advancement. These conditions include syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and mandibular micrognathia. The device's purpose is to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones.

The provided text focuses on the device's mechanical performance rather than clinical efficacy studies. Therefore, acceptance criteria and performance are reported for mechanical characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (Cohen Distractor)
Frame Stiffness (compared to predicate devices)	Significantly greater than MULTI-GUIDE™ and Vazquez-Diner devices
Average Yield Strength (compared to predicate devices)	Significantly greater than MULTI-GUIDE™ device; Slightly lower than Vazquez-Diner device

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The number of Cohen Distractor units, Vazquez-Diner Distractor units, and MULTI-GUIDE™ distractor units tested for static cantilever bend testing is not explicitly stated. The text only mentions "the Cohen Distractor and two currently available and legally marketed distraction devices."
Data Provenance: The data is from mechanical testing conducted as part of the 510(k) submission process. This is a controlled engineering study, not
clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for this study is based on objective measurements from static cantilever bend testing, not expert interpretation or consensus of clinical data. The mechanical properties are physical characteristics.

4. Adjudication method for the test set:

Not applicable. This was a mechanical engineering study, not an evaluation of clinical outcomes requiring adjudication. The results would be quantitative measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This was a pre-market submission for a physical medical device (bone distractor), not an AI-powered diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. As stated above, this device is a bone distractor, not an algorithm or AI system.

7. The type of ground truth used:

The "ground truth" here is the objective measurement of mechanical properties (frame stiffness and yield strength) obtained through controlled laboratory testing (static cantilever bend testing) on the devices.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not a machine learning algorithm. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established:

Not applicable. There is no training set for this type of device.

Summary

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510(k) SUMMARY

K972154

Device Proprietary Name:	Cohen Distractor
Device Common Name:	Bone Distractor
Classification Name:	Smooth or Threaded Metallic Bone FixationFastener 21 CFR 888.3040
Name of Submitter:	Howmedica Leibinger Inc.
Contact Person:	John F. DichiaraGroup Manger of Regulatory AffairsHowmedica Leibinger Inc.359 Veterans BlvdRutherford, NJ 07070
Telephone:	201-507-7836
Fax:	201-507-6870
Date Prepared:	6/5/97

Summary:

This submission describes a bone distraction system intended for use in the treatment of cranial, midfacial, or mandibular conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and mandibular micrognathia. The device is intended to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones. This device is a distraction system consisting of the following major components; distractor frame, plates, machine screws, flexible shaft, and distraction key. The plates and frame initially stabilize and then gradually distract the osteotomy. The flexible shaft, covered with a protective sheath, is connected to the frame and provides the point of attachment for the key used to initiate the distraction of the osteotomy.

Static cantilever bend testing was conducted on the Cohen Distractor and two currently available and legally marketed distraction devices, the Vazquez-Diner Distractor and the MULTI-GUIDE™ distractor (a.k.a. the Howmedica Mandibular Bone Distractor II). The results of the testing demonstrated that the Cohen Distractor had a significantly greater frame stiffness compared to the MULTI-GUIDE™ and Vazquez-Diner devices. The Cohen Distractor had an average yield strength which was significantly greater than the average yield strength of the MULTI-GUIDE™ device, and was slightly lower than the Vazquez-Diner device. It is not anticipated that this difference will have any relevance in the clinical setting because of the low forces observed in patients who are treated with all of these devices.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Vazquez - Diner Intraoral Distractor (Howmedica Leibinger K964649); the Mandibular Bone Distractor II (Howmedica K960297); the Normed Distractor (Ace Surgical Supply [US Distributor] K # Unknown); the Lubr Small Fixation Plating System (Howmedica K950595) and the Synthes Midface Plating System (Synthes) K953806.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John F. Dichiara Group Regulatory Affairs Manager Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584

AUG 1 1 1997

Re: K972154 K972166 Trade Names: Cohen Distractor Guerrero-Bell Distractor Regulatory Class: II Product Code: JEY Dated: June 6, 1997 Received: June 9, 1997

Dear Mr. Dichiara:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification

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Page 2 - Mr. John F. Dichiara

submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

[signature]

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ludications for Use

长972154 STO(k) Number (if Known)

Device Name

I cibinger Cohen Distractor

Indications for Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDITHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K
Prescription Lise
(Per 21 CFR 801 109)

Over-The-Counter Use

(Optional Format 1-2-96)

collid

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.